"
Nearly 2,600 people died between 2005 and 2012 on account of dubious testing on unregistered drugs in India. According to a parliamentary report, there were 352,475 people enrolled in pharmaceutical tests between 2009 and 2012. In January 2013, the Supreme Court of India castigated the government "for being negligent in curbing illegal clinical trials."
According to Frost & Sullivan, a market research firm, the domestic drugs trial market in 2011 in India was worth $485 million and is expected to grow to $1 billion by 2016.
However, the larger concern around illegal trials, poor regulatory implementation and the doctor-pharmaceutical company-government nexus poses a stiff challenge to an otherwise valid and needed industry.
India has emerged as an attractive destination for global clinical research, considered important for the discovery of new drugs and treatments that are not yet available to the public. It gives access to participants to expert medical care at leading healthcare facilities.
However, the reality is quite different because of the doctors and pharmaceutical companies forming a cabal that experiments illegally on unaware patients.
The case of Maharaja Yeshwantrao Hospital in Indore has been in the news for running 73 clinical trials in the past few years on 3,300 patients, of which about 1,800 were children.
The doctors were lured with foreign trips and illegal payments, and in turn paid local government officials to turn a blind eye. The story is confirmed in other parts of India as well.
Interestingly, the firms, the doctors and the hospitals comply with all the formalities by filling out consent forms, compensation information and jargon-heavy explanations for patients who cannot even write their names.
A recent BBC exposure reported many stories of illiterate parents being forced to sign "English" forms for privileged and expensive treatments. The patients are told that they are being treated under some government scheme.
Responding to a public interest litigation, the Supreme Court of India took matters into its own hands, and directed the government to implement stricter laws and ethical practices for clinical trials in India.
It has now become a regulatory mandate that a drug can only be launched if its trial is conducted within the country.
There are new laws for regulation and ethical supervision of trials; compensation of trial subjects; and mandatory accreditation of all stakeholders - institutional review boards, research institutions, sponsors and contract research organizations.
The Drugs Controller General of India made it mandatory to register ethics committees. All trials should be registered at the Clinical Trials Registry of India. The rules have discouraged pharmaceutical companies from applying for new trials, severely affecting India's clinical research market.
The number of clinical trials which peaked in 2010 with approvals of as many as 500 trials has seen a constant decline with only 325 in 2011 and 262 trials being granted approval last year. The US National Institutes of Health recently cancelled approximately 40 ongoing clinical trials in India.
As the debate on using humans as guinea pigs rages across Asia, the rationale for developing new drugs, new treatments and new research is equally stronger.
The solution lies somewhere in between where governments, pharmaceutical companies and those in medical profession have to wear ethical hats and delineate profit from greed.
The governments have to establish norms and processes to facilitate clinical research and also safeguard social interest and exploitation.
The pharmaceutical companies even in intensified competition have to resort to ethical industry-wide practices which may appear less rewarding in the short run but may have long-term social and economic benefits.
Finally, medical practitioners have to rise above personal greed and be righteous in one of the only professions in the world which has the power to save lives.
(The author is a Programme Advisor with Observer Research Foundation, New Delhi)
Courtesy : The Global Times, Beijing, July 29, 2013
"
The views expressed above belong to the author(s). ORF research and analyses now available on Telegram! Click here to access our curated content — blogs, longforms and interviews.
PREV
